BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 22572040 · Received July 22, 2025

    Report

    Report Number
    9610847-2025-00229
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    June 23, 2025
    Report Date
    October 16, 2025
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE 4 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED UPON INSPECTION OF THE PHOTOS. ANALYSIS OF THE SAMPLE SHOWED THAT IN ONE PHOTO IT SHOWS AN UNKNOWN BLACK PARTICLE IN THE NON-FLUID PATH OF THE SYRINGE BELOW THE STOPPER. HOWEVER, BD CANNOT CONFIRM THE CAUSE OF THE FAILURE SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE OF THE REPORTED FAILURE. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 309703 BATCH # 5072050 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DEBRIS IN SYRINGE MATERIAL # BD 309703 (5ML SYRINGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2037214 BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 5072050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown